Risk-Stratification Directed Prophylaxis with Additional Low-Dose of Methylprednisolone Can Reduce Acute Graft-Versus-Host Disease for Patients with Hematological Malignancies after Allogeneic SCT: A Randomized, Controlled, Clinical Trial

Abstract The major complication of allogeneic HSCT-graft-versus-host disease (GVHD)-remains lethal and limits use of this important procedure, especially after unmanipulated haploidentical HSCT. Several studies have provided evidence that universal addition of corticosteroids for prophylaxis of GVHD can reduce the risk for acute GvHD grade II-IV in HLA-matched transplantation. However, corticosteroid, a non-specific immunosuppressive agent, may also contribute to high rates of infections. Our previous data suggest that the ratio of CD4/CD8 in allografts from haploidentical donors can stratify patients into high-risk and low-risk ones who will develop GVHD after transplantation. Recently, we indicated that low-dose of methylprednisolone (MP, 0.5 mg/kg/day) might be a well-tolerated, effective and inexpensive regimen in combination of MTX for therapy of GVHD, suggesting that low-dose corticosteroid may be used for the prophylaxis of GVHD without increasing infection. To investigate whether risk-stratification directed prophylaxis strategy can reduce the incidence of GVHD and improve survival in a hemogenous patient population who underwent unmanipulated haploidentical HSCT, we performed a prospective, randomized, controlled, clinical trial. A total of 228 patients were enrolled in this trial. All of the patients completed the study and were stratified as high-risk (n=145) and low-risk arms (n=83) according to the ratio of CD4/CD8 in allografts. Patients of the high-risk arms were randomly assigned in a 1:1 ratio to additional low-dose glucocorticoid prophylaxis group (Group A, n=72) and control group (GroupB, n=73). The groups were balanced with respect to patient and donor characteristics. Our results showed that the cumulative incidence of grade II-IV acute GVHD on day 100 was 20.9%±4.8% in Group A, which was comparable to Group C (25.5%±4.8%, P=0.430) and both of which were significantly lower than that of Group B (48.1%±5.9%, P＜0.001). In addition, the onset time of grade II-IV acute GVHD was 25 (16-50) days, 15 (9-57) days, and 21 (10-58) days, respectively in Group A, Group B, and Group C (P＜0.05, Group A vs. Group B or Group C). There were no significant difference in grade Ⅲ-IV acute GVHD among these three groups. The ratio of patients who developed glucocorticoid refactory acute GVHD and treated with basiliximab (anti-CD25 antibody) were 13.9% (10/72), 17.8% (13/73), and 22.9% (19/83), respectively, in Group A, Group B, and Group C, there is a trend that the incidence of basiliximab treated patients in Group C is higher than that of Group A (P=0.109). The median time for myeloid engraftment in Group A was 11 days (range: 10-21 days), which was significantly faster that those of Group B (13 days, range from 10 to 33 days, P＜0.05) and Group C (13 days, range from 10 to 33 days, P＜0.05). The median time for platelet engraftment in Group A was 12 days (range: 10-22 days), which was significantly faster that those of Group B (17 days, range from 6 to 255 days, P＜0.01) and Group C (19 days, range from 8 to 260 days, P＜0.01). In addition, risk-stratification directed prophylaxis with additional low-dose of MP did not increase the incidence of CMV, EBV reactivation, PTLD, relapse and TRM, as well as delay immune recovery after unmanipulated haploidentical HSCT. The 100 day cumulative incidence relapse and transplant-related mortality was not significantly different among patients in Group A, Group B, and Group C, respectively. The 100 day probabilities of LFS and OS were comparable among these three patient groups. In conclusion, we for the first time demonstrated that risk-stratification directed prophylaxis for GVHD with additional low-dose of MP could significantly decrease the incidence and delay the onset of grade II-IV acute GVHD without increasing infections and delaying immune recovery. Our data indicated that addition of glucocorticoid early after unmanipulated haploidentical transplantation could also accelerate hematopietic recovery [This study was registered at http://clinicaltrials.gov/ NCT01607580]. Disclosures No relevant conflicts of interest to declare.

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Controlled, Randomized, Open-Label Trial of Risk-Stratified Corticosteroid Prevention of Acute Graft-Versus-Host Disease After Haploidentical Transplantation

Journal of Clinical Oncology ◽

10.1200/jco.2015.63.8817 ◽

2016 ◽

Vol 34 (16) ◽

pp. 1855-1863 ◽

Cited By ~ 45

Author(s):

Ying-Jun Chang ◽

Lan-Ping Xu ◽

Yu Wang ◽

Xiao-Hui Zhang ◽

Huan Chen ◽

...

Keyword(s):

High Risk ◽

Low Dose ◽

Acute Gvhd ◽

Open Label ◽

Platelet Recovery ◽

Graft Versus Host ◽

Haploidentical Transplantation ◽

Group A ◽

Dose Corticosteroid ◽

Group B

Purpose This study evaluated whether a prophylaxis strategy directed by the graft-versus-host disease (GVHD) biomarker might reduce the 100-day incidence of acute GVHD grades II to IV. Patients and Methods This controlled, open-label, randomized trial included 228 patients who underwent haploidentical transplantation. On the basis of bone marrow allogeneic graft CD4:CD8 ratios, patients were categorized as low risk (n = 83; group A) or high risk (n = 145). Patients at high risk were randomly assigned to either receive (n = 72; group B) or not receive (n = 73; group C) low-dose corticosteroid prophylaxis. Results The incidence in group B was 21% (95% CI, 11% to 31%) compared with 26% (95% CI, 16%to 36%; P = .43) in group A and 48% (95% CI, 32% to 60%; P < .001) in group C. Low-dose corticosteroid prophylaxis was significantly associated with a relatively low risk of acute GVHD grades II to IV (hazard ratio, 0.66; 95% CI, 0.49 to 0.89; P = .007) and rapid platelet recovery (hazard ratio, 0.30; 95% CI, 0.23 to 0.47; P < .001). The incidence of moderate-to-severe chronic GVHD in group B (21%) was lower than that in both group A (50%; P = .025) and group C (36%; P = .066). The 100-day corticosteroid doses were 205 ± 111 mg in group B, 229 ± 149 mg in group A (P = .256), and 286.54 ± 259.67 mg in group C (P = .016). Compared with group C, group B showed significantly lower incidences of femoral head necrosis (P = .034) and hypertension (P = .015). Infection rates were comparable among these groups. Conclusion Our results suggest that risk stratification–directed, low-dose corticosteroid prophylaxis significantly decreased the incidence of acute GVHD grades II to IV, accelerated platelet recovery, and reduced adverse events without increasing infections.

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Impact of the 25-Hydroxycholecalciferol Concentration and Vitamin D Deficiency Treatment on Changes in the Bone Level at the Implant Site during the Process of Osseointegration: A Prospective, Randomized, Controlled Clinical Trial

Journal of Clinical Medicine ◽

10.3390/jcm10030526 ◽

2021 ◽

Vol 10 (3) ◽

pp. 526

Author(s):

Jakub Kwiatek ◽

Aleksandra Jaroń ◽

Grzegorz Trybek

Keyword(s):

Vitamin D ◽

Vitamin D Deficiency ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Group A ◽

Bone Level ◽

Group B ◽

Implant Treatment ◽

Correct Level ◽

25 Hydroxycholecalciferol

Introduction: The most important factor which is responsible for the positive course of implant treatment is the process of osseointegration between the implant structure and the host’s bone tissue. The aim of this study was to assess what effect the 25-hydroxycholecalciferol concentration and vitamin D deficiency treatment have on changes in the bone level at the implant site during the process of osseointegration in the mandible. Materials and Methods: The study was with 122 people qualified for implant surgery, who were assigned to three research groups (A, B, and C). Laboratory, clinical, and radiological tests were performed on the day of surgery, and after 6 and 12 weeks. The bone level in the immediate proximity of the implant was determined by radiovisiography (RVG). Results: The bone level after 12 weeks in Groups B and C was significantly higher than after 6 weeks. The bone level in the study Group B was significantly higher than in Group A. The study showed that the higher the levels of 25-hydroxycholecalciferol were observed on the day of surgery, the higher was the level of bone surrounding the implant after 6 and 12 after surgery. Conclusion: The correct level of 25-hydroxycholecalciferol on the day of surgery and vitamin D deficiency treatment significantly increase the bone level at the implant site in the process of radiologically assessed osseointegration.

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Venous thromboembolism prevention protocol for adapting prophylaxis recommendations to the potential risk post total knee replacement: a randomized controlled trial

Pharmacy Practice ◽

10.18549/pharmpract.2020.3.2025 ◽

2020 ◽

Vol 18 (3) ◽

pp. 2025

Author(s):

Mariam A. Alameri ◽

Syed A. Syed Sulaiman ◽

Abdullah M. Ashour ◽

Ma’ad F. Al-Saati

Keyword(s):

Randomized Controlled Trial ◽

Patient Education ◽

Risk Stratification ◽

Controlled Trial ◽

Education Programs ◽

Randomized Controlled ◽

Group A ◽

Total Knee ◽

The Mean ◽

Group B

Background: Total knee replacement (TKR) is a major orthopedic surgery that is considered high risk for the development of venous thromboembolism (VTE). Objective: The aim of this study is to evaluate the clinical outcomes that resulted from the use of a new proposed VTE risk stratification protocol for selecting a suitable extended VTE prophylaxis for post TKR surgery patients administered in conjunction with patient education programs. Method: A randomized controlled trial was conducted in two medical centers in Saudi Arabia. A total of 242 patients were enrolled in the study, 121 patients in each group. The experimental group (A) was assessed by using the proposed VTE risk stratification protocol and also took part in patient education programs about TKR and its complications. The control group (B) was assessed by using the 2005 Caprini risk assessment tool and no education programs were given to this group. Both groups were followed for 35 days post operation. Results: The mean age of the participants was 65.86 (SD 8.67) and the majority of them were female 137 (56.6%). The mean body mass index of the study sample was 32.46 (SD 5.51). There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p˂0.05). There were no confirmed pulmonary embolism cases in the study sample and diagnosis of deep-vein thrombosis was confirmed in 12/242 (5.0%) of patients: 1/121 (0.8%) in group A and 11/121 (9.1%) in group B (p˂0.05). The readmission rate for all patients was 2.5% (6/242), all of whom were in group B (p˂0.05). Conclusion: The proposed VTE risk stratification protocol that was applied in conjunction with patient education programs reduced VTE complications and readmission events, post TKR surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04031859.

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A Comparison of Clinical Outcomes of Non-T-Cell-Depleted (Non-TCD) Unrelated Donor Heamatopietic Stem Cell Transplantation (HSCT) and Non-TCD Haploidentical Related Donor HSCT.

Blood ◽

10.1182/blood.v108.11.5140.5140 ◽

2006 ◽

Vol 108 (11) ◽

pp. 5140-5140

Author(s):

Feng Chen ◽

De Pei Wu ◽

Aining Sun ◽

Xiao Ma ◽

Xiaowen Tang ◽

...

Keyword(s):

Bone Marrow ◽

Stem Cell ◽

High Risk ◽

Acute Gvhd ◽

Peripheral Blood Stem Cell ◽

Ex Vivo ◽

Unrelated Donor ◽

Group A ◽

Related Donor ◽

Group B

Abstract Unrelated donor HSCT and haploidentical related donor HSCT have been evaluated as alternative transplant options for the approximately 70% of patients without an HLA-identical sibling donor. To compare the clinical outcomes between Non-TCD unrelated donor HSCT and Non-TCD haploidentical HSCT, we studied 55 patients with high-risk or advanced leukemia who underwent Non-TCD HSCT from unrelated or haploidentical related donors from June 2001 to May 2006. Group A including 25 patients received HLA-matched unrelated donor HSCT, group B, including the other 30 patients, received HLA-haploidentical family donor HSCT. 20 recipient/donor pairs were allele matched and 5 pairs were 1–2 alleles disparity mismatched in the group A, HLA-haploidentical family donors in the group B included mother (22 cases), sibling(5 cases) and offspring (3 cases). Patients with myeloid leukemia were conditioned with the regimen consisting of Simustine (MeCCNU) 250mg/m2×1day, Ara-c 4g/ m2×2days, busulfan (Bu) 4mg/kg×3days, and cyclophosphamide (Cy)1.8g/m2×2days, patients with lymphoblastic leukemia were conditioned with the regimen consisting of MeCCNU 250mg/m2×1day, total-body irradition(TBI) 8Gy×1day, Ara-c 4g/ m2×2days, and Cy 1.8g/m2×2days. 15 patients received Non-TCD bone marrow transplantation (BMT), and 10 patients received Non-TCD peripheral blood stem cell transplantation (PBSCT) in the group A. 17 patients received G-CSF-primed bone marrow grafts that had not been depleted ex vivo of T cells, and 13 patients received G-CSF-primed bone marrow grafts plus G-CSF-mobilized peripheral blood stem cell without ex vivo T cell depletion in the group B. Prophylaxis against GVHD was performed with cyclosporine (CSP), short-term methotrexate (MTX), and mycophenolate mofetil (MMF), some patients received the combination of CSP, MTX and MMF plus antithymocyte globulin (ATG). When GVHD developed, methylprednisolone(MP) was given at first, if the response was poor, anti-CD25 monoclonal antibody was given to the patients as quickiy as possible and CSP was replaced with tacrolimus. All patients of the group A and 29 patients of the group B were engrafted successfully. Acute GVHD grades III-IVoccurred in 10 and 11 patients in the group A and B, respectively(the cumulaitive incidence 40% vs 37.9%, P>0.05). 2 patients relapsed in each group (the actuarial probilities of relapse 8% vs 6%, P>0.05). The 2-year probabilities of event-free survival(EFS) for the group A and B were (58.7±5.9)% and (42.2±2.0)%, respectively (P>0.05). 10 patients of the group A and 17 of the group B died of transplantation- related disease. The primary causes of death included severe acute GVHD and pulmonary infection. These results suggested that both Non-TCD unrelated donor HSCT and Non-TCD haploidentical related donor HSCT are effective treatments for patients with refractory or high-risk hematologic malignancies, the high transplantation related mortality due to GVHD and infection is still a major challenge.

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The Effect of Costimulatory Moleculars on Graft-Versus-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation.

Blood ◽

10.1182/blood.v110.11.4875.4875 ◽

2007 ◽

Vol 110 (11) ◽

pp. 4875-4875

Author(s):

Zhenhua Qiao ◽

Fang Ye ◽

Lei Zu

Keyword(s):

Stem Cell ◽

T Cell ◽

Stem Cell Transplantation ◽

Cell Transplantation ◽

Acute Gvhd ◽

Chronic Gvhd ◽

Hematopoietic Stem ◽

Graft Versus Host ◽

Group A ◽

Group B

Abstract Objective: To explore the effect of costimulatory molecular and CD25 expressed on peripheral CD4+ T lymphocytes on graft-versus-host disease(GVHD) after allogeneic hematopoietic stem cell transplantation(allo-HSCT). Methods: 1. The 21 patients who suffered of hematology diseases or malignant solid tumors and were underwent allo-HSCT and 10 normal individuals were enrolled in the study.2. For the sake of difference conditioning regimens we divided the 21 patients into two groups: patients undergoing non-myeloablative stem cell transplantation(NST) belonged to group A, others undergoing traditional myeloablative stem cell transplantation belonged to group B; we divided them into five groups for with GVHD or without GVHD and types of GVHD: group 1(group A with acute GVHD), group 2(group A with chronic GVHD), group 3(group B with acute GVHD), group 4(group B without GVHD), group 5(group A without GVHD).3. The levels of CD28, CD80, CD152 and CD25 expressions on peripheral CD4+ T lymphocytes were detected by three colors flow cytometry (FCM)in different time(before allo-HSCT,7days,14days,21days,30days after allo-HSCT, the time of GVHD and the time after GVHD treated).4.STR-PCR for detecting micro-satellites chimeras forming. Results: 1. All 21 patients achieved engraftment. By STR-PCR assay,12 cases formed complete chimeras(CC) and 9 cases formed mixed chimeras(MC). In group A,3 cases developed acute GVHD and 4 cases developed chronic GVHD; in group B,4 cases developed aGVHD. The incidence of GVHD and infection rates between group A and B has no difference(X2=3.711, P=0.144).2. Among these 21 cases,5 cases died:2 cases died of multiple organs function failure due to primary disease relapse,1 case died of bleeding in brain and 2 cases died of liver function failure for the sake of complicated with acute GVHD; others survive with disease free till present.3. The results of multivariate logistic regression models and Kaplan-Meier survival curves analyses showed: age, sex, infection, HLA-type, blood type, conditioning regiment and the times of absolute neutrophil counts and platelets recovering to normal, had no association with the incidence of GVHD;A multivariate COX survival function model analysis showed CD4CD152 and CD4CD25 are independent prognostic factors for GVHD(X2=13.128, P<0.0001).4. Patients with GVHD demonstrated higher CD4+CD28+ and CD4+CD80+ T cell levels than those without GVHD(P<0.01);patients with aGVHD demonstrated higher than those with cGVHD(P<0.05) and without GVHD(P<0.05); Patients with GVHD demonstrated lower CD4+CD152+ and CD4+CD25+ T cell levels than those without GVHD(P<0.01); the same result occurs between aGVHD and cGVHD and without GVHD. After effective treatment, unnormal CD4+CD28+, CD4+CD80+, CD4+CD152+ and CD4+CD25+ T cell levels recovered to the levels before transplantation. Conclusions: The incidences of GVHD between NST and traditional myeloablative stem cell transplantation had no difference. B7-CD28/CD152 costimulatory pathway plays a critical role in developing of GVHD. Peripheral CD4+CD28+, CD4+CD80+, CD4+CD152+ and CD4+CD25+ T cell levels were relative to recipient GVHD, especially CD4+CD152+ and CD4+CD25+ T cell levels. Down-grade CD4+CD28+ and CD4+CD80+ T cell levels and up-grade CD4+CD152+ and CD4+CD25+T cell levels could reduce the incidence of GVHD.

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Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

BIRDEM Medical Journal ◽

10.3329/birdem.v7i3.33783 ◽

2017 ◽

Vol 7 (3) ◽

pp. 216-220

Author(s):

Md Mehedi Hasan ◽

Samira Rahat Afroze ◽

Muhammad Abdur Rahim ◽

Muhammad Abdus Salam

Keyword(s):

Controlled Trial ◽

Ethical Review ◽

Control Group ◽

Controlled Clinical Trial ◽

Transurethral Resection Of Prostate ◽

Randomized Controlled ◽

Significant Difference ◽

Group A ◽

The Mean ◽

Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

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The role of HLA-DPB1 disparity in the development of acute graft-versus- host disease following unrelated donor marrow transplantation

Blood ◽

10.1182/blood.v81.7.1923.1923 ◽

1993 ◽

Vol 81 (7) ◽

pp. 1923-1932 ◽

Cited By ~ 81

Author(s):

EW Petersdorf ◽

AG Smith ◽

EM Mickelson ◽

GM Longton ◽

C Anasetti ◽

...

Keyword(s):

Graft Versus Host Disease ◽

Marrow Transplantation ◽

Acute Gvhd ◽

Unrelated Donor ◽

Host Disease ◽

Graft Versus Host ◽

Group A ◽

Group B ◽

Acute Graft

Abstract The role of HLA-DPB1 disparity in the development of acute graft-versus- host disease (GVHD) following unrelated donor (URD) marrow transplantation is unknown. We studied 129 patients who underwent marrow transplantation from HLA-A, -B, -DRB, and -DQB matched URDs to determine whether matching for HLA-DPB1 alleles significantly decreased the risk of developing acute GVHD. HLA-DPB1 alleles were determined by sequence-specific oligonucleotide hybridization and by the number of patient DPB1 alleles not shared by the donor scored. The Kaplan-Meier probability of developing grades II to IV acute GVHD was determined for patients incompatible for zero (group A), one (group B), or two (group C) DPB1 alleles. Of the 129 pairs, there was no recipient DPB1 incompatibility in 28 (22%), one DPB1 mismatch in 72 (56%), and two DPB1 mismatches in 29 (22%). The probability of grades II to IV acute GVHD was 0.69 (0.50, 0.86) for group A, 0.83 (0.73, 0.91) for group B, and 0.72 (0.56, 0.87) for group C (P = .63). These results indicate that matching patients and unrelated donors for HLA-A, -B, -DRB, and - DQB does not predict for matching at DPB1. However, recipient incompatibility for DPB1 alleles does not detectably influence the risk of acute GVHD. Therefore, HLA-DP disparity should not be used as an exclusion criterion for donor selection in unrelated marrow transplantation.

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Risk stratification–directed donor lymphocyte infusion could reduce relapse of standard-risk acute leukemia patients after allogeneic hematopoietic stem cell transplantation

Blood ◽

10.1182/blood-2011-09-380386 ◽

2012 ◽

Vol 119 (14) ◽

pp. 3256-3262 ◽

Cited By ~ 175

Author(s):

Chen-Hua Yan ◽

Dai-Hong Liu ◽

Kai-Yan Liu ◽

Lan-Ping Xu ◽

Yan-Rong Liu ◽

...

Keyword(s):

Risk Stratification ◽

Acute Leukemia ◽

Low Dose ◽

Disease Free Survival ◽

Donor Lymphocyte Infusion ◽

Hematopoietic Stem ◽

Group A ◽

Group B ◽

The Impact ◽

Standard Risk

Abstract We studied the impact of risk stratification–directed interventions for minimal residual disease (MRD) on relapse and disease-free survival (DFS) prospectively in 814 subjects with standard-risk acute leukemia receiving allotransplantation in first or second complete remission. A total of 709 subjects were MRD− after transplantation (Group A); 105 subjects were MRD+, 49 received low-dose IL-2 (Group B), and 56 received modified donor lymphocyte infusion (DLI) with or without low-dose IL-2 (Group C). Posttransplantation immune suppression for GVHD was also modified based on MRD state. The cumulative risk of relapse was significantly less and DFS was significantly better in subjects in Group C than in subjects in Group B (P = .001 and P = .002, respectively), but was not different from subjects in Group A (P = .269 and P = .688, respectively). Multivariate analyses confirmed that MRD state and modified DLI were significantly correlated with relapse (P = .000, odds ratio [OR] = 0.255 and P = .000, OR = 0.269) and DFS (P = .001, OR = 0.511 and P = .006, OR = 0.436, respectively). These data suggest that risk stratification–directed interventions with modified DLI in patients with standard-risk acute leukemia who are MRD+ after transplantation may improve transplantation outcomes.

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Efficacy and safety of intralesional triamcinolone acetonide in the treatment of chronic hand eczema

Bangabandhu Sheikh Mujib Medical University Journal ◽

10.3329/bsmmuj.v10i3.33458 ◽

2017 ◽

Vol 10 (3) ◽

pp. 129

Author(s):

Tasnuva Ashraf ◽

Harashit Kumar Paul ◽

Md. Shahidullah Sikder ◽

A. S. M. Zakaria ◽

Saiful Islam Bhuiyan ◽

...

Keyword(s):

Triamcinolone Acetonide ◽

Severity Index ◽

Hand Eczema ◽

Clobetasol Propionate ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Chronic Hand Eczema ◽

Group A ◽

Group B

This randomized controlled clinical trial was conducted to assess the efficacy and safety of intralesional triamcinolone acetonide in the treatment of chronic hand eczema comparing with topical clobetasol propionate. A total 60 patients of chronic hand eczema were recruited in the study. Thirty patients (Group A) were treated with intralesional triamcinolone acetonide and the rest 30 (Group B) with topical clobetasol propionate. Severity and improvement were assessed using Hand Eczema Severity Index (HECSI) score. The patients of both groups were followed up at 4th week and 12th week. In Group A, median HECSI score at baseline, 4th week and 12th week were 3, 20 and 20 respectively; whereas these scores were 54, 10 and 8 in Group B. In both groups, HECSI score was decreased gradually but the rate was higher in Group B than Group A (p<0.05). Thinning of skin, an adverse effect, was seen in patients of both the intralesional triamcinolone acetonide (10%) and topical clobetasol propionate (16.7%) groups (p>0.05). The result of this study demonstrates that intralesional triamcinolone acetonide is effective and safe in treating chronic hand eczema but less effective than the topical clobetasol.

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Increase of PlGF (Placental Growth Factor) Level After Administration of Dydrogesterone in Pregnancy

KnE Medicine ◽

10.18502/kme.v1i1.530 ◽

2016 ◽

Vol 1 (1) ◽

Cited By ~ 1

Author(s):

Dewi Karlina Rusly

Keyword(s):

Folic Acid ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Significant Difference ◽

Before And After ◽

Group A ◽

Study Population ◽

The Mean ◽

Group B ◽

In Pregnancy

Aim: To observe the effect of Dydrogesterone administration in pregnancy on PlGF levelMethods: This is a randomized controlled clinical trial. Study population has been divided into two groups. Group A consists of 20 women who receive only Folic acid 5 mg a day for 4 weeks time. Group B consists of 20 women who receive Dydrogesterone 2x10 mg a day and Folic acid 5 mg a day for 4 weeks. PlGF has been measured twice. First measurement was done before drug administration, while the second measurement has been done during 18th weeks of pregnancy. The changes on PlGF level before and after treatment from each group has been analyzed using SPSS 17.Results: 40 pregnant women have been recruited for this study. There are no differences based on the patient’s age, number of pregnancy and parity, gestational age and body weight between each group. The mean levels of PlGF in both groups before intervention shows no significant difference (p = 0091 or p> 0.05), 40.80 pg/mL vs. 25.95 pg / mL. The mean levels of PlGF in group A after 4 weeks administration of Folic acid is 89.60 pg / mL. It shows the escalation of 48.8 pg / mL. The elevation of PlGF level in group A shows significant difference (p = 0.000 or p <0.05) after 4 weeks Folic acid treatment.The mean levels of PlGF in group B after 4 weeks administration of Dydrogesterone and Folic acid is 212.15 pg / mL. It shows the escalation of 186.20 pg / mL. The elevation of PlGF level in group B shows significant difference (p = 0.000 or p <0.05) after 4 weeks Dydrogesterone and Folic acid treatment.Conclusion: Dydrogesterone treatment can increase the level of PlGF.

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